BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACT/ALERT FN CULTURE BOTTLE

    MDR report key: 3522438 · Received December 4, 2013

    Report

    Report Number
    3002769706-2013-00005
    Event Type
    Death
    Date Received
    December 4, 2013
    Date of Event
    November 25, 2013
    Report Date
    December 4, 2013
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    MDB
    PMA / PMN Number
    K121455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PSEUDOMONAS IS NOT TYPICALLY ISOLATED FROM ANAEROBIC BLOOD CULTURE BOTTLES (I.E. FN CULTURE BOTTLE). IF THE PARTICULAR SPECIES OF PSEUDOMONAS CAN GROW IN ANAEROBIC CONDITIONS, IT MAY BE POSSIBLE TO PRODUCE ENOUGH GROWTH IN THE ANAEROBIC BOTTLE TO BE SIGNALED POSITIVE. THE BACT/ALERT COLORIMETRIC TECHNOLOGY IS BASED ON CO2 PRODUCTION WITHIN THE BOTTLE. PSEUDOMONAS TYPICALLY DOES NOT PRODUCE A LARGE AMOUNT OF CO2; THEREFORE, THE RATE OF CHANGE IN A BACT/ALERT GRAPH WILL TYPICALLY BE INSUFFICIENT TO SIGNAL POSITIVE BY THE ASSOCIATED ALGORITHM. DELAYED LOADING OF THE FN CULTURE BOTTLE INTO THE BACT/ALERT INCUBATOR WILL INCREASE THE LIKELIHOOD OF NO DETECTION. BASED ON THE INFO PROVIDED BY THE CUSTOMER, THERE IS NO INDICATION OF THE FOLLOWING: EVIDENCE THAT THE PT UNDERWENT ANY UNNECESSARY MEDICAL PROCEDURE DUE TO THE REPORTED EVENT. PHYSICIAN ALLEGING THE REPORTED EVENT CAUSED HIM/HER TO PROVIDE INCORRECT OR DELAYED TREATMENT. THE REPORTED ISSUE COULD BE A CONTINUING PROBLEM AND POTENTIALLY HARM OTHER PTS OR STAFF MEMBER. THERE WAS ALSO NO REPORTED DELAY IN TREATMENT OR NEGATIVE IMPACT TO A PT DUE TO THE BACT/ALERT FN CULTURE BOTTLE RESULT. THE ASSOCIATED FA (AEROBIC) CULTURE BOTTLE PROVIDED A POSITIVE GROWTH SIGNAL BY WHICH TREATMENT DECISIONS COULD BE MADE. THERE IS NO EVIDENCE OF A PRODUCT MALFUNCTION OR INDICATION THAT THE BACT/ALERT INSTRUMENT OR BACT/ALERT FN CULTURE BOTTLE RESULT CAUSED OR CONTRIBUTED TO THE PT'S DEATH. BECAUSE THE BACT/ALERT CANNOT BE ELIMINATED AS A POTENTIAL CONTRIBUTING CAUSE TO THE PT DEATH, WE ARE REPORTING THE EVENT WHILE INTERNAL INVESTIGATION OCCURS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A CUSTOMER IN INDIA REPORTED A FALSE NEGATIVE FOR PSEUDOMONAS IN A BACT/ALERT FN CULTURE BOTTLE; THE CORRESPONDING FA CULTURE BOTTLE SIGNALED "POSITIVE" FOR PSEUDOMONAS. THE CUSTOMER LEFT THE FN CULTURE BOTTLE IN THE BACT/ALERT INCUBATOR FOR FIFTEEN DAYS; THE BOTTLE REMAINED "NEGATIVE" WITH NO APPARENT COLOR CHANGE OF THE BOTTLE SENSOR. DURING THIS INITIAL CONTACT ON (B)(6) 2013, THE CUSTOMER NOTIFIED BIOMERIEUX THAT THE PT HAD EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED BY THE HOSPITAL; AND ANY PRE-EXISTING CONDITIONS ARE UNK, AND WILL NOT BE PROVIDED BY THE HOSPITAL DUE TO PRIVACY POLICIES. THE HOSPITAL IS NOT FORTHCOMING WITH ANY HOSPITAL DOCUMENTATION RELATED TO THE EVENT. THE CUSTOMER IS UNWILLING TO REVEAL ANY DETAILS REGARDING THE PT, PRE-EXISTING CONDITIONS, TESTING, TREATMENT OR TIMELINE OF EVENTS. THEREFORE, NO DETERMINATION CAN BE MADE REGARDING POTENTIAL CAUSE OR CONTRIBUTION OF BIOMERIEUX BACT/ALERT OR FN CULTURE BOTTLE PRODUCTS TO THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628062 BACT/ALERT FN CULTURE BOTTLE BACT/ALERT FN MDB BIOMERIEUX, INC. 1036246

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death